This Program Announcement expires on January 10, 2005, unless reissued.

RESEARCH ON ALCOHOL AND HIV/AIDS

Release Date:  December 17, 2001

PA NUMBER:  PA-02-039 


See Replacements PA-07-028 (R01), PA-07-064 (R03) and PA-07-063 (R21) 

National Institute on Alcohol Abuse and Alcoholism
 (http://www.niaaa.nih.gov)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR INSTRUCTIONS 
MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR 
BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) 
AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks 
applications to support research to identify and characterize the role of 
alcohol, drinking behaviors, and drinking environments in the epidemiology and 
natural history, pathogenesis, prevention, treatment and control of HIV/AIDS. 

The goal of this Program Announcement is to encourage multidisciplinary, 
interdisciplinary, and collaborative studies that focus on a range of 
epidemiologic and intervention issues within HIV and alcohol.  It advances  
research goals set forth in the NIH Fiscal Year 2002 Plan for HIV-Related 
Research.  Relevant objectives identified in the plan include:

o Characterize the relative importance of alcohol and drug use in the 
acquisition and subsequent transmission of HIV in order to identify and apply 
appropriate alcohol and drug use interventions as public health measures.

o Investigate the social and environmental factors that contribute to HIV 
infection, behaviors after infection, and co-occurring conditions (e.g., 
substance use, mental illness, homelessness, hepatitis, STDs, tuberculosis), 
including the causes and implications of stigma.

This Program Announcement is intended to appeal to a broad audience of alcohol 
and HIV/AIDS researchers, including alcohol researchers with no prior experience 
in HIV/AIDS research, but with a keen appreciation for the relationship between 
problem drinking and HIV/AIDS and a strong interest in acquiring such 
experience, HIV/AIDS researchers with no prior alcohol research experience who 
realize the importance of more intensive alcohol interventions to improving 
clinical outcomes among HIV+ individuals, and those with prior research 
experience in the area of co-occurring HIV/AIDS and alcohol and other substance 
abuse. Given the breadth of research objectives included in this announcement, 
potential applicants are encouraged to carefully review all sections of the 
announcement for research opportunities.       

HEALTHY PEOPLE 2010 

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This Program Announcement, 
Research on Alcohol and HIV/AIDS, is related to one or 
more of the priority areas. Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS 

Applications may be submitted by domestic and foreign for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal Government.  Faith-based organizations are eligible to apply for 
these grants.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators. 

MECHANISMS OF SUPPORT 

This PA will use the National Institutes of Health (NIH) research project grant 
(R01), exploratory/developmental grant (R21), and small grant (R03)award 
mechanisms.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  Applicants for R01s may 
request support for up to 5 years. Applications requesting direct costs of 
$500,000 or more in any one year must obtain written agreement from the NIAAA 
that the application will be accepted for consideration of award, in accordance 
with NIH policy, which is available at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.  
Currently, small grants (R03) are limited to 2 years for up to $50,000 per year 
for direct costs, and exploratory/developmental grants (R21) are limited to 
$100,000 per year for direct costs for up to 3 years. Exploratory/developmental 
grants and small grants cannot be renewed, but grantees may apply for R01 
support to continue research on the same topics. 

BACKGROUND

Alcohol consumption and its consequences together with HIV/AIDS are major 
public health burdens in many parts of the world. Chronic abusive alcohol use 
can lead to life threatening organ system damage. Light to moderate 
consumption can induce behavioral and organ system changes which may influence 
HIV transmission, pathogenesis, and disease progression.  There is overlap 
between persons at risk for alcohol-related problems and individuals at risk for 
HIV infection. Regardless of the level consumed, alcohol is likely to influence 
the health status and behaviors of persons infected with HIV and those whose 
behaviors place them at risk for acquiring the virus.

An estimated 14 million Americans suffer from alcohol abuse and dependence and 
an additional 50,000 new cases of HIV infection are reported each year. 
Estimates of the co-occurrence of alcohol abuse/dependence among individuals 
infected with HIV range from approximately 30 to 70% in different samples. For 
example, more than 60% of HIV-infected participants in the MIDAS (Miami HIV 
Infected Drug Abuser Study) reported current heavy alcohol use. The prevalence 
of alcohol dependence among HIV-infected men is approximately three times that 
of women, and both prevalences substantially exceed those for alcohol dependence 
for men and women in the U.S. population overall. As HIV/AIDS research becomes 
more focused, there is growing evidence that alcohol consumption may play an 
important role in sexual transmission, susceptibility to infection, and 
progression of HIV disease. In addition, alcohol use, abuse, and dependence may 
have a significant impact on the occurrence and course of comorbid conditions  
such as HCV and TB, adherence to medications and provider advice, provider and 
patient attitudes towards treatment, and survival.

Special emphasis has been given to research which examines the effectiveness of 
interventions that extend beyond the level of the individual, with the aim of 
bringing all of the resources of a given community to bear on the twin epidemics 
of alcohol and other substance abuse and HIV/AIDS.  This focus is, in turn, 
consistent with goals articulated by the international AIDS research community 
in its attempt to stem the spread of HIV/AIDS in resource poor areas of the 
world.  With increasing knowledge of the dimensions of the HIV epidemic in parts 
of Asia and Africa has come heightened awareness of the critical importance of 
involving community members as equal partners in every aspect of the research 
process.

In addition to being a possible risk factor in the contraction and progression 
of HIV disease, alcohol misuse is likely to impact adherence to complex HIV 
medication regimens and to physician advice. Recent evidence has indicated 
interactive effects of alcohol use and HIV infection on brain functioning and 
cognitive processes. Whether alcohol consumption increases susceptibility to 
opportunistic infections in HIV+ patients and whether alcohol-induced 
immunosuppression affects pathogenesis and disease progression are important 
questions. However, carrying out research on the effects of alcohol consumption 
and drinking behaviors on HIV-related health outcomes is challenging. While 
clinical findings have associated increased levels of chronic alcohol 
consumption with diminished immune function, as evidenced by reduced levels of 
CD4 and CD8 activity, many questions about the relationship between alcohol 
consumption, increased susceptibility to HIV infection, and accelerated 
progression to AIDS remain unanswered. Strain variations of HIV, individual 
differences in susceptibility, long incubation time following seroconversion and 
varying patterns of adherence to HIV medications are only some of the challenges 
in studying disease progression. Comorbid mental and somatic illnesses and 
environmental stress are additional confounding factors.  It is therefore of 
continuing importance to conduct research which seeks to clarify the role of 
alcohol in HIV transmission and disease progression, and to develop and test 
preventive interventions which both reduce the risk of alcohol-related HIV 
transmission and improve the treatment of HIV infected alcohol abusing and/or 
alcohol dependent individuals.

RESEARCH OBJECTIVES 

The complex and global nature of unresolved questions surrounding alcohol and 
HIV/AIDS relationships indicates the need for a multidisciplinary approach to 
research. Investigators representing a broad array of academic 
disciplines and engaged in cross-cutting fields of science are encouraged to 
consider designing hypotheses-driven studies that utilize rigorous 
methodologies from epidemiological, clinical, and experimental research.  
Special emphasis areas include:

Epidemiology and Natural History of Alcohol Use and HIV/AIDS: Improved 
understanding of the epidemiology of alcohol use, abuse, and dependence in HIV 
infection and AIDS will help to identify high-risk groups and promote 
development of effective HIV prevention and treatment efforts, including medical 
management of HIV/AIDS disease. For example, studies are needed to: 

o Gain insight into the alcohol-HIV/AIDS relationship through population-based 
research on alcohol consumption patterns of groups at-risk for HIV infection. 

o Identify and model the impact of alcohol consumption patterns on the spread of 
HIV infection and associated opportunistic infections over time.

o Examine patterns of HIV infection and variability in strains of HIV in heavy 
drinking populations both in the U.S. and abroad to guide vaccine development.

o Characterize alcohol use and alcohol use disorders in high-risk groups with 
HIV/AIDS and co-occurring medical and psychiatric conditions.

o Describe more fully the role of gender, race/ethnicity, cultural and 
environmental factors in the intersection of alcohol and HIV/AIDS epidemics.

o Examine the impact of alcohol-related social policies, including those 
affecting legal and illegal alcohol production, access, taxation, etc., on the 
spread of HIV and other STDs.

Prevention of HIV Risk Behaviors Related to Alcohol: Behavioral, affective, 
and cognitive factors affect the risk for HIV infection and the efficacy of 
HIV prevention and treatment among alcohol users and abusers.  Models should 
be developed for interrelating these individual factors with contextual and 
social factors that influence alcohol misuse, sexual risk-taking, and other 
HIV risk behaviors. Development and testing of new interventions are needed 
at various levels, including: individual, dyadic, social network, 
organizational, and community.  The following areas are suggested and not 
exclusive: 

o Develop community-based interventions, e.g., bar-based server training, to 
alter alcohol availability and to improve linkage of alcohol and HIV preventive 
services.

o Develop school-based interventions, including middle school, high school, and 
college curricula focusing on the relationship between alcohol-related sexual 
risk behaviors and HIV/AIDS.

o Target and retain the highest risk drinkers (including those from difficult-
to-reach, underserved populations)in HIV/STD prevention and treatment 
interventions - including trials for prophylactic vaccines. 

o Motivate drinkers-including those who perceive themselves to be at low risk 
for HIV infection-to decrease risky sexual and substance use behaviors.

o Assess relationship of alcohol consumption, alcohol-related sexual 
expectancies, social norms, and decision-making on HIV risk behaviors.

o Develop and test preventive interventions based on social dynamics and 
environmental characteristics of high-risk alcohol-related settings and 
situations (e.g., bars, parties, neighborhoods with a high density of drinking 
outlets, etc.).

o Develop and test family and peer group interventions to reduce alcohol use, 
unsafe behavior and exposure to co-occurring risks such as violence, poor health 
care and disease.

o Improve methods for assessing and analyzing complex relationships between 
alcohol use and abuse, psychological, and environmental factors, including 
alcohol regulations and policies, and HIV-related risk behaviors. 

Medical Aspects of Treatment Among HIV-Positive Individuals with Alcohol Use 
Disorders: Alcohol use may be a key determinant in disease transmission and 
progression, adherence and response to therapeutic regimens, among other 
effects. Still many questions remain unanswered with regard to how the co-
occurrence of HIV/AIDS and alcohol abuse/dependence currently influences 
clinical decision making, and how provider practices could be modified to 
improve clinical outcomes. Research is needed to determine whether and how 
alcohol affects disease progression in various organ systems in HIV+ 
individuals, to develop and evaluate pharmacological interventions for the 
treatment of alcohol dependence in HIV+ individuals, to guide the development of 
HIV treatment regimens tailored to the needs of people with coexisting alcohol 
abuse/dependence, and to improve motivation for treatment and adherence to 
treatment.  Specifically research efforts are needed to:

o Develop and test therapeutic regimens which are based on a)drug-drug 
interactions between alcohol and antiretroviral medications, b)changes in drug 
metabolism in individuals with alcohol-related liver dysfunction and other 
physiologic impairments, c)results of testing for drug resistance, and 
d)lifestyle factors in heavy drinking populations (e.g., structured treatment 
interruptions, salvage therapies, etc.).

o Study the effects of alcohol on the transmission of HIV from mothers to 
children.
 
o Compare the efficacy of various pharmacological interventions for the 
treatment of alcohol dependence (e.g. Naltrexone) in HIV+ individuals.

o Advance understanding of the dynamics between alcohol use and abuse and 
adherence to HIV therapeutic regimens, and test strategies to improve compliance 
with HIV therapeutic regimens.

o Investigate mechanisms by which alcohol consumption affects liver disease 
progression in individuals with HIV, including those coinfected with hepatitis C 
(HCV), to improve clinical outcomes in heavy drinking populations.

o Improve guidelines for prophylaxis and treatment of opportunistic infections 
by examining the relationship between alcohol-related host defense impairment 
and the emergence and course of disease caused by pathogens such as M. 
tuberculosis, S. pneumoniae, P. carinii and HCV.

o Investigate impact of alcohol on HIV-specific complications including 
neuropathogenesis and pathogenic processes involved in AIDS dementia, peripheral 
neuropathy, cardiomyopathy, enteropathy and wasting, among other conditions.

o Study the impact of alcohol on fat redistribution and other aspects of fat, 
protein, and carbohydrate metabolism and nutrition in individuals with HIV/AIDS.

o Enhance linkage of primary medical care with alcohol prevention and treatment 
services for HIV-infected alcohol abusers.

o Improve medical technology for rapid diagnosis and determination of HIV 
genetic subtypes and drug resistance patterns in heavy drinking and other high-
risk populations.

Multi-level Behavioral and Psychosocial Approaches to the Treatment of 
Individuals with Co-occurring HIV/AIDS and Alcohol Abuse/Dependence: The 
implementation of research-based behavioral/psychosocial interventions which 
will complement state-of-the-art pharmacologic interventions for the treatment 
of alcohol dependence in HIV+ individuals will be critically important to the 
achievement of improved clinical outcomes.  Research is needed to better 
characterize and address the impact of behavioral and psychosocial factors on 
access to treatment and on drinking and HIV/AIDS outcomes, and to ameliorate 
negative behavioral, affective, physical, cognitive and social consequences of 
HIV infection in alcohol-using and -abusing populations through multilevel 
interventions.  Such interventions may target, separately or in combination, 
individuals, families, treatment programs and networks of programs, and 
communities.  Specifically, research efforts are needed to:

o Integrate alcohol risk reduction goals into HIV/AIDS treatment programs, 
including behavioral, psychosocial, and pharmacological interventions.  Evaluate 
effectiveness of behavioral/psychosocial interventions to help individuals stop 
drinking and avoid relapse. Develop tailored treatments as needed for special 
populations such as underserved minorities, pregnant women, and those with 
comorbid psychiatric diagnoses.

o Integrate HIV risk reduction goals into alcohol abuse treatment programs, 
including behavioral, psychosocial, and educational interventions.  Evaluate the 
effectiveness of HIV risk reduction strategies in alcohol treatment settings. 
Develop tailored treatments as needed for special populations such as 
underserved minorities, pregnant women, and those with comorbid psychiatric 
diagnoses.

o Develop and test interventions to improve the quality of life of individuals 
with coexisting HIV/AIDS and alcohol use disorders (e.g., strategies to reduce 
the impact of alcohol-related consequences on social, family, vocational 
functioning and well-being, and on the course of AIDS-related illnesses.)

o Increase knowledge of effective collaborative approaches to the organization 
and management of services for HIV-positive adolescent alcohol abusers, 
including analyses of barriers to access and utilization of services, and 
strategies to overcome them (e.g., mobile vans as a means for improving health 
care access by alcohol abusers).

o Improve understanding of the relationship between alcohol use and abuse, 
access to care, and delivery and cost of services for infected persons. 

Biological Research on Alcohol and HIV/AIDS: Lack of knowledge on the influence 
of alcohol on HIV infectivity and viral replication is a major 
impediment to understanding HIV-related morbidity and mortality.  Therefore, 
research that provides detailed knowledge of how alcohol and HIV, each in its 
own way or acting in concert, usurp host defense mechanisms and co-opt vital 
cellular machinery to enhance viral replication is urgently needed. 
Biological research that delineates the multiple effects of alcohol and 
HIV on host defense mechanisms and disease progression will provide a rational 
basis for the development of new methods of therapeutic intervention. The 
following topics serve to illustrate the types of research that would be 
responsive to this PA:

o Effects of alcohol on viral burden, immune function, and organ system 
dysfunction in HIV infected individuals or appropriate animal models. 

o Organ system changes at the cellular, molecular and tissue levels that may 
influence infectivity, viral load, disease progression and/or therapeutic 
response.

o Animal models of alcohol consumption and AIDS to explore cellular changes and 
immune state dynamics.

o New in vitro models to characterize the effects of alcohol on the response of 
cellular systems to HIV (e.g., blood brain barrier, placental barrier, etc.) 

o Drug-drug interactions between alcohol and antiretroviral drugs, including 
altered pharmacokinetics, metabolism and toxicity due to chronic or acute 
alcohol consumption.

Community-Based Participatory Research:  Community-based participatory research 
in public health is a partnership approach to research that equitably involves, 
for example, community members, organizational representatives, and researchers 
in all aspects of the research process.  The partners contribute their expertise 
and share responsibilities and ownership to enhance understanding of a given 
phenomenon, and to integrate the knowledge gained with action to improve the 
health and well-being of community members.  This Announcement seeks to promote 
community-based participatory research because it represents a critical 
distinction from "community-based research," which emphasizes conducting 
research in a community as a place or setting, rather than conducting research 
with members of a community who are full and equal partners.  Such research 
recognizes the community as a social and cultural entity with the active 
engagement and influence of community members in all aspects of the research 
process.  Within the area of community-based participatory research, suggested 
special emphasis areas include:

o Research on the characteristics of community-based organizations and 
coalitions most likely to be successful in implementing effective science-based 
interventions in at-risk communities.

o Studies which identify and evaluate outcome measures and data collection 
systems appropriate to the evaluation of research-based HIV prevention 
interventions implemented in community settings.

o Research on models for facilitating cooperation among research and service 
professionals.

o Studies of the mechanisms by which institutions network with other community 
agents and other community institutions.  When and how do such connections and 
collaborations improve HIV and AOD prevention efforts?  When and how do they 
fail to do so?

o Multi-level collaborative research to study patterns of communication between 
various sectors of society (e.g., Federal, state, and local governments, 
community-based service organizations, and the business community, etc.) and 
their impact on the delivery of prevention, intervention, and treatment services 
to individuals with coexisting HIV/AIDS and alcohol use disorders.
 
o Programs of community-based participatory research involving U.S.-supported 
researchers and researchers in other nations to evaluate community-level 
strategies to arrest the spread of HIV infection and its consequences. 

Dissemination and Diffusion of Research Findings:  Despite advances in our 
knowledge of effective approaches to preventing HIV infection, it is clear that 
information, strategies, and models for HIV prevention have not always reached 
community program levels.  Likewise, information developed by community programs 
has frequently not reached or influenced HIV prevention researchers.  It is 
extremely important that more effective collaborative relationships between the 
research community and the community of public organizations delivering 
prevention programs to high-risk populations be developed in such a way that a 
sustainable research infrastructure is established and/or enhanced at the level 
of local communities.  Models of technology transfer need to be developed and 
validated in large-scale community settings.  These models must include 
effective training for community providers as well as ongoing assessment of what 
happens to research-based interventions when they are put into practice.  
Critical to the success of these efforts will be an awareness of the cultures in 
which the interventions were undertaken and ways in which existing interventions 
may have to be modified to be successful.  Interventions which leave in place 
infrastructures capable of complex problem solving, program evaluation, and 
ongoing two-way communication with the research community should facilitate 
future technology transfer.  

Suggested areas of research include but are not limited to:

o Studies that develop and test different models for transferring effective 
research-based HIV prevention interventions into relatively resource poor 
communities.

o Studies of mechanisms that would enable community-based organizations to 
advise and communicate with the research community on needed research to improve 
responses to ongoing or emerging HIV-related public health issues.

o Collaborative programs to train minority investigators to conduct clinical, 
biomedical, and prevention research which explores the impact of alcohol abuse 
on HIV transmission, disease progression, and clinical outcomes.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research projects 
unless a clear and compelling justification is provided indicating that 
inclusion is inappropriate with respect to the health of the subjects or the 
purpose of the research. This policy results from the NIH Revitalization Act of 
1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) all 
applications or proposals and/or protocols must provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable, and b) investigators 
must report annual accrual and progress in conducting analyses, as appropriate, 
by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  This 
policy applies to all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

DATA AND SAFETY MONITORING PLAN

As of the October 2000 receipt date, applicants must supply a general 
description of the Data and Safety Monitoring Plan for ALL clinical trials, this 
must be included in the application 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.

The degree of monitoring should be commensurate with risk. NIH Policy for Data 
and Safety Monitoring requires establishment of formal Data and Safety 
Monitoring Boards for multi-site clinical trials involving interventions that 
entail potential risk to the participants. The absence of this information will 
negatively affect your priority score.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH solicitation, 
internet addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the Internet sites.  
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a project 
that is supported in whole or in part with Federal funds and (2) cited publicly 
and officially by a Federal agency in support of an action that has the force 
and effect of law (i.e., a regulation) may be accessed through FOIA.  It is 
important for applicants to understand the basic scope of this amendment.  NIH 
has provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a description 
of the archiving plan in the study design and include information about this in 
the budget justification section of the application. In addition, applicants 
should think about how to structure informed consent statements and other human 
subjects procedures given the potential for wider use of data collected under 
this award.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying 
for these grants and will be accepted at the standard application deadlines 
(http://grants.nih.gov/grants/dates.htm) as indicated in the application kit.  
This version of the PHS 398 is available in an interactive, searchable format. 
Although applicants are encouraged to begin using the 5/2001 revision of the PHS 
398 as soon as possible, the NIH will continue to accept applications prepared 
using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, 
however, the NIH will return applications that are not submitted on the 5/2001 
version.  For further assistance contact GrantsInfo, Telephone 301/710-0267, 
Email:  [email protected].

Applicants planning to submit an investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended/revised version of 
the preceding grant application types requesting $500,000 or more in direct 
costs for any year are advised that he or she must contact the Institute or 
Center (IC) program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from the IC staff that the IC will accept the application for 
consideration for award.  Finally, the applicant must identify, in a cover 
letter sent with the application, the staff member and Institute or Center who 
agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of the 
original application as well as any subsequent revisions.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 

The modular grant concept establishes specific modules in which direct costs may 
be requested as well as a maximum level for requested budgets.  Only limited 
budgetary information is required under this approach.  The just-in-time concept 
allows applicants to submit certain information only when there is a possibility 
for an award.  It is anticipated that these changes will reduce the 
administrative burden for the applicants, reviewers and NIH staff.  The research 
grant application form PHS 398 
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 
is to be used in applying for these grants, with modular budget instructions 
provided in Section C of the application instructions.  Although applicants are 
encouraged to begin using the 5/2001 revision of the PHS 398 as soon as 
possible, the NIH will continue to accept applications prepared using the 4/1998 
revision until January 9, 2002. Beginning January 10, 2002, however, the NIH 
will return applications that are not submitted on the 5/2001 version.  For 
further assistance contact GrantsInfo, Telephone 301/710-0267, 
Email:  [email protected].

Submit a signed, typewritten original of the application, including the 
Checklist, and five signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines. Applications will be evaluated for scientific and technical merit by 
an appropriate scientific review group convened in accordance with the standard 
NIH peer review procedures. As part of the initial merit review, all 
applications receive a written critique and undergo a process in which only 
those applications deemed to have the highest scientific merit, generally the 
top half of the applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the National Advisory 
Council on Alcohol Abuse and Alcoholism. 

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written comments reviewers will be asked to discuss the following aspects of the 
application in order to judge the likelihood that the proposed research will 
have a substantial impact on the pursuit of these goals.  Each of these criteria 
will be addressed and considered in assigning the overall score, weighting them 
as appropriate for each application.  Note that the application does not need to 
be strong in all categories to be judged likely to have major scientific impact 
and thus deserve a high priority score.  For example, an investigator may 
propose to carry out important work that by its nature is not innovative but is 
essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims of 
the application are achieved, how will scientific knowledge be advanced?  What 
will be the effect of these studies on the concepts or methods that drive 
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or method?  
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be done 
contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the research.  
Plans for the recruitment and retention of subjects will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

Additional considerations pertinent to the review of Exploratory/Developmental 
Grant (R21) applications:

Pilot/feasibility studies may contain little or no preliminary data.  Review 
should focus on  whether  the rationale for the study is well developed and 
whether the proposed research is likely to generate data that will lead to a 
regular research project grant or full-scale clinical trial.  Adequate 
justification for the proposed work may be provided through literature 
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES 

Inquiries concerning this PA are encouraged. The opportunity to clarify any 
issues or questions from potential applicants is welcome. 

Direct inquiries regarding programmatic issues related to general NIAAA research 
priorities to: 

Kendall Bryant, Ph.D.
Scientific Coordinator Alcohol and HIV/AIDS Research, NIAAA
Chief, Collaborative and Special Health Programs Branch
Office of Collaborative Research 
Suite 302
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard  MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 402-9389
FAX:  (301) 480-2358
Email: [email protected]

Direct inquires regarding programmatic issues related to collaborative and 
medical research

Deidra Roach, M.D.
Office of Collaborative Research 
Suite 302
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard  MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-5820
FAX:  (301) 480-2358
Email:  [email protected]

Direct inquiries regarding programmatic issues related to epidemological 
research to:

Vivian Faden, Ph.D.
Chief, Division of Biometry and Epidemiology 
Suite 514 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard
Bethesda, MD  20892-7003.  
Telephone:  (301) 594-6232

Direct inquiries regarding programmatic issues related to the clinical and 
prevention research to:

Margaret Mattson, Ph.D. 
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard
Bethesda, MD  20892-7003
Telephone:  (301) 443-0638
Fax:  (301) 443-8774
E mail:  [email protected]

Direct inquiries regarding programmatic issues related to basic biological 
research to:

Denise Russo, Ph.D.
Chief, Division of Basic Research
Suite 402
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard
Bethesda, MD  20892-7003
Telephone:  (301) 402-9403
Fax:  (301) 594-0673
E mail:  [email protected]

Direct inquiries regarding fiscal matters to:

Judy Fox Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 executive Blvd. (MSC-7003)
Bethesda, MD  20892-7003
(For express mail use:
Rockville, MD  20852)
Telephone:  (301) 443-2434
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.273.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 
92.  This program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the PHS 
mission to protect and advance the physical and mental health of the 
American people.

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